System and method for collecting data and managing patient care

ABSTRACT

A care management system in which the management of the administration of care for patients is automated. Hospital information systems are monitored and the information from those systems is used in verifying the administrations of care to patients. The care management system monitors ongoing administrations for progress and automatically updates records and provides alarms when necessary. The care management system is modular in nature but is fully integrated among its modules. Particular lists of data, such as the termination times of all ongoing infusions, provide hospital staff current information for increased accuracy and efficiency in planning. Features include the automatic provision of infusion parameters to pumps for accurate and efficient configuration of the pump, and providing an alarm when an unscheduled suspension of an infusion exceeds a predetermined length of time. A passive recognition system for identifying patients and care givers is provided.

CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This is a continuation-in-part of application Ser. No.08/440,625, filed on May 15, 1995.

BACKGROUND OF THE INVENTION

[0002] The invention relates generally to systems for managing patientcare in a health care facility, and more particularly, to systems forcollecting data and controlling the delivery of patient care.

[0003] Medical institutions are faced with a competitive environment inwhich they must constantly maintain or improve profitability and yetsimultaneously improve patient care. Several factors contribute to theever increasing costs of health care, whether it is delivered to thepatient in a hospital or out-patient clinic setting. Health caredeliverers face increased complexity in the types of treatment andservices available, but also must provide these complex treatments andservices efficiently, placing a premium on the institution's ability toprovide complex treatment while maintaining complete and detailedmedical records for each patient.

[0004] It is also advantageous to have a care management system thatcombines all of the various services and units of a health careinstitution into an interrelated automated system to provide“just-in-time” delivery of therapeutic and other drugs to the patient.Such a system would prevent administering an inappropriate medication toa patient by checking the medication against a database of knownallergic reactions and/or side-effects of the drug against the patent'smedical history. The interrelated system should also provide doctors,nurses and other care-givers with updated patient information at thebedside, notify the institution's pharmacy when an additional drug isrequired, or when a scheduled treatment is running behind schedule, andautomatically update the institution's accounting database each time amedication or other care is given.

[0005] Inaccurate recording of the administration of drugs and usage ofsupplies involved in a patient's treatment results in decreasingrevenues to the institution by failing to fully capture billingopportunities of these actual costs. Inadequate management also resultsin a failure to provide an accurate report of all costs involved intreating a particular illness.

[0006] In many hospitals and clinical laboratories, a bracelet devicehaving a patient's name printed thereon is permanently affixed to apatient upon admittance to the institution in order to identify thepatient during his or her entire stay. Despite this safeguard,opportunities arise for patient identification error. For example, whena blood sample is taken from a patient, the blood sample must beidentified by manually transcribing the patient's name and otherinformation from the patient's identification bracelet. In transferringthe patient's name, a nurse or technician may miscopy the name or mayrely on memory or a different data source, rather than actually readingthe patient's bracelet.

[0007] Moreover, manually transferring other information, such as theparameters for configuring an infusion pump to dispense medication mayresult in errors that reduce the accuracy and/or effectiveness of drugadministration and patient care. This may result in an increasedduration of treatment with an attendant increase in costs.

[0008] Hospitals and other institutions must continuously strive toprovide quality patient care. Medical errors, such as where the wrongpatient receives the wrong drug at the wrong time, in the wrong dosageor even where the wrong surgery is performed, are a significant problemfor all health care facilities. Many prescription drugs and injectionsare identified merely by slips of paper on which the patient's name andidentification number have been handwritten by a nurse or technician whois to administer the treatment. For a variety of reasons, such as thetransfer of patients to different beds and errors in marking the slipsof paper, the possibility arises that a patient may be given anincorrect treatment. This results in increased expense for the patientand hospital that could be prevented using an automated system to verifythat the patient is receiving the correct care.

[0009] Various solutions to these problems have been proposed, such assystems that use bar codes to identify patients and medications, orsystems allowing the bedside entry of patient data. While these systemshave advanced the art significantly, even more comprehensive systemscould prove to be of greater value.

[0010] What has been needed, and heretofore unavailable, is anintegrated, modular system for tracking and controlling patient care andfor integrating the patient care information with other institutionaldatabases to achieve a reliable, efficient, cost-effective delivery ofhealth care to patients. The invention fulfills these needs and others.

SUMMARY OF THE INVENTION

[0011] Briefly and in general terms, the present invention provides anew and improved patient management system capable of monitoring,controlling and tracking the administration of care in a health careinstitution.

[0012] Generally, the patient management system comprises a number ofCPUs having a variety of input and output devices for receiving patientdata and for generating or displaying reports. A system of softwareprograms operates on the CPUs to record, process, and produce reportsfrom a database whose data is representative of the care a patientreceives in the institution. The CPUs are connected together, along withat least one dedicated file server, to form a network. Patient data isinput by users of the personal computers, and is stored in a datastorage device connected to the file server.

[0013] More specifically, in a more detailed aspect by way of exampleand not necessarily of limitation, the patient management systemincludes a pharmacy computer, a nursing station CPU including a videodisplay and printer and bedside CPUs connected to various clinicaldevices such as infusion pumps for providing medication to a patient anda barcode reader for reading barcode labels either affixed to thepatient's identification bracelet or a label on a medication container.In operation, the patient management system verifies that the rightmedication is being dispensed to the right patient in the right dosagevia the right delivery route at the right time by maintaining a databaseof information relating to the patient, the patient's condition, and thecourse of treatment prescribed to treat the patient's illness.

[0014] The patient wears an identification device that includes abarcode that can be read by a barcode reader connected to the bedsideCPU. Medication to be administered to the patient in the course of thepatient's treatment is identified with a label that is printed by abarcode printer in the pharmacy or by the manufacturer's suppliedbarcodes on unit dose packaging. When the medication is administered tothe patient by a care-giver, the care-giver uses the barcode readerconnected to the bedside CPU to read the barcode on the patient'sidentification device and the barcode on the label identifying themedication to be dispensed. The patient management system compares thepatient's identity with the medication and verifies that it is thecorrect medication for the patient. Additionally, the caregiver may alsohave an identification device that bears a barcode with the caregiver'sname and other information. Using the barcode reader, the care giver'sidentity can thus be stored in the database and linked to the treatmentgiven to the patient to ensure complete and accurate tracking of alltreatment given to the patient.

[0015] In another aspect, an identification system is provided that ispassive in nature. That is, the system operates to automatically detectand identify an individual, such as a patient and/or caregiver withoutany particular action being required on the part of the individual. In afurther aspect, an RF transponder is mounted at a patient's room ortreatment area and automatically detects an identification device, suchas a wrist band, on the individual to identify the individual. Theidentification device may comprise an electrical circuit.

[0016] In a further aspect, the patient management system also includesthe capability of recording the present location of each clinical devicein the institution, and maintains a history of the device usage in adevice usage and event database. This database may also include ahistory of a device's maintenance and calibration.

[0017] In another aspect, the patient management system includes theability to track usage of consumable supplies within the various unitsof the health care institution. This assists in managing the inventoryof consumable supplies to ensure that supplies are always available. Afurther advantage is that it enables the institution's administration toproject supply usage and thus purchase supplies in quantities thatensure cost discounts without incurring excessive inventory carryingcosts.

[0018] In yet another aspect, the patient management system employs RF(radio frequency) transmitters and receivers to connect the varioushardware elements of the system together into a local area network. Thisaspect is advantageous in that it provides increased flexibility inpositioning of the hardware elements of the network while eliminatingthe need for costly network wiring throughout the institution.

[0019] These and otber advantages of the invention will become apparentfrom the following more detailed description when taken in conjunctionwith the accompanying drawings of illustrative embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

[0020]FIG. 1 is a graphic representation of a care management systemincorporating principles of the present invention and illustratingdetails of the hardware elements and local area network;

[0021]FIG. 2 is a functional block diagram of the care system of FIG. 1additionally showing an interface with other institutional informationmanagement systems;

[0022]FIG. 3 is a functional block diagram of the software modules thatcomprise the care system of FIGS. 1 and 2;

[0023]FIG. 4 is a graphic representation of a patient identificationbracelet including a barcode that can be read by a barcode reader;

[0024]FIG. 5 is a drawing of a barcode label affixed to a medicationcontainer that can be read by a barcode reader;

[0025]FIG. 5A is a drawing showing a barcode label affixed to acaregiver identity badge;

[0026]FIG. 6 is a drawing showing a sheet of barcode labels that can beaffixed to various containers or devices;

[0027]FIG. 7 is a graphical representation of a display on an infusionpump showing the name of a drug being infused along with otherinformation relating to the infusion;

[0028]FIG. 8 presents a computer screen listing of the infusions inprogress showing the drug being administered, the time remaining, andthe patient's name;

[0029]FIG. 9 shows a patient IMAR (integrated medication administrationrecord) showing scheduled medications and windows around the scheduledtimes;

[0030]FIG. 10 shows a computer screen task list for a partial floor of ahospital in which times for administration in a certain time period areset out along with the patient name and drug to be administered;

[0031]FIG. 11 shows a computer screen used for rescheduling theadministration of an order;

[0032]FIG. 12 presents a computer screen containing an overview of apartial floor of a hospital in which various patients rooms are shownwith the names of the patient;

[0033]FIG. 13 is a graphical representation of another embodiment of thecare management system showing the clinical devices connected to thelocal area network through a bedside data concentrator;

[0034]FIG. 14 is a graphical representation of still another embodimentof the care management system showing the clinical devices transmittingand receiving information from the local area network through RFtransmitting/receiving equipment;

[0035]FIG. 15 is a graphical representation of another embodiment of thecare management system of FIG. 9 where all of the hardware elements ofthe local area network communicate with each other using RFtransmitting/receiving equipment; and

[0036]FIG. 16 presents a view of a patient having an identificationdevice located on his arm that interacts with a transmitter/receiverlocated in the frame of the entry/exit of the room in which the patientis located. The identification device and transmitter/receiver form apassive identification system in accordance with an aspect of theinvention.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0037] Referring now to the drawings, and more particularly to FIG. 1,there is shown generally an integrated hospital-wide information andcare management system 30 including one embodiment of the point-of-caremanagement system 30 of the present invention. The care managementsystem embodiment shown in FIG. 1 is depicted as being configured as alocal area network with a file server 45 to which are connected apharmacy computer 60, a nursing station 70, and bedside CPUs 80. Thefile server 45 stores programs and data input and collected by thevarious computers in the local area network. Various application modulesof the patient management system may be resident in each of thecomputers in the network and will be discussed in more detail below.Ethernet cabling of a local area network 50 is used to connect variousCPUs to the file server. The file server 45 also has both local andnetwork hard disk storage for storing programs as well as data gatheredon the network.

[0038] Referring now to both FIGS. 1 and 2, a functional block diagramof the patient care management system 30 of FIG. 1 is shown in FIG. 2interfaced with and connected to other hospital information managementsystems to form an integrated information and care management system.This information and care management system is integrated with acombination of individual hospital systems, such as the pharmacyinformation system 20, and the hospital administration system 40 whichare interconnected via a network 5 and appropriate interfaces 10. Eachof the various systems 20, 30 and 40 generally comprise a combination ofhardware such as digital computers which may include one or more centralprocessing units, high speed instruction and data storage, on-line massstorage of operating software and short term storage of data, off-linelong-term storage of data, such as removable disk drive platters, CDROMs, or magnetic tape, and a variety of communication ports forconnecting to modems, local or wide area networks, such as the network5, and printers for generating reports. Such systems may also includeremote terminals including video displays and keyboards, touch screens,printers and interfaces to a variety of clinical devices. The operatingsystems and specific software applications will be described in moredetail below.

[0039] The care management system 30 of FIGS. 1 and 2 includes a fileserver 45, such as an IBM or IBM compatible personal computer havingsufficient mass storage 46, such as local hard drives, CD ROM, magnetictape, or other media, and appropriate communication interfacecapabilities to interconnect with other hardware comprising the point ofcare management system. Although many configurations are possible, inone embodiment the file server would include hardware such as a datacommunication router, a large hard drive to store data for the entirenetwork, and communication hardware for communicating with the hospitalnetwork. Additionally, a separate computer (CPU) is used to communicatewith, control and provide an interface gateway 27 to the hospitalnetwork 5.

[0040] A local area network 50, comprising a thin net, or ethernetcabling is used to connect the central file server 45 to the hardwarethat comprises the care management system.

[0041] In the present embodiment, the file server 45 of the caremanagement system is connected by a local area network (LAN) 50 tocomputers and other peripheral equipment located in the institution'spharmacy, at nursing stations located throughout the institution, and atthe patient's bedside. In the embodiment shown, the module located inthe pharmacy comprises a central processing unit 60 to which is attacheda video display 64 and a keyboard 62 for entry and display of patientinformation and drug parameters. Also attached to the pharmacy CPU is abar code reader 68 which is adapted to read barcode labels that may beattached to drug containers, equipment, or caregiver identificationbadges as will be more fully discussed below. Also connected to thepharmacy CPU 60 is a bar code printer 69 and a printer 66 used forgenerating reports containing information about patient history and/orpatient treatment. The printer 66 may also be used to print barcodelabels generated by the pharmacy CPU 60 after patient or drug data isinput by a technician or pharmacist into the pharmacy computer 60 usingthe keyboard 62 or other means.

[0042] Another computer, herein referred to as the nursing CPU 70, islocated at a nursing station. Nursing stations are typically located invarious sections and/or floors of a hospital or clinic and typicallyprovide a central location for record storage and monitoring for anumber of patient beds. The nursing CPU 70 located at the nurse stationtypically includes a video display 74 for displaying patient or otherinformation pertaining to the operation of the particular unit of theinstitution, and a keyboard 72, mouse, touch screen 73, or other meansfor entering patient data or specific commands instructing the nursingCPU 70 to generate reports relating to either the patient's medicalhistory or the course and progress of treatment for an individualpatient on the attached printer 76 or on the video display 74. As willbe discussed more fully below, the nursing station CPU 70 may alsogenerate other reports such as, for example, a printout of drugsscheduled to be administered to patients, productivity measurements suchas, for example, the amount of time a nurse spends with a patient orother reports useful for assisting in the efficient operation of theparticular unit or the hospital. For example, a report listing theactual times of administration versus the scheduled times foradministration may be prepared to assist in evaluation of staffingrequirements.

[0043] Each care unit associated with the nursing station typicallycomprises one of more patient beds located in private rooms, sharedrooms, or open or semi-open wards that contain multiple beds. Inaccordance with an embodiment of the present invention, each privateroom, semi-private room, or ward area has at least one bedside CPU 80for monitoring and treating one or more patients. Each bedside CPU 80has a video display 84 and a keyboard 82, mouse, touch screen 83, orother device. The bedside CPU 80 can be used by a nurse, physician ortechnician to access a variety of institutional databases to display avariety of information about a particular patient. This information caninclude an on-line, real-time, graphical patient medicationadministration record (MAR) that is derived from the patient'smedication profile maintained by the hospital's pharmacy informationsystem 20. The bedside CPU 80 also allows remote access to a patient'srecords stored by the file server 45 to display medication history forthe patient. This medication history includes a listing of all drug orother treatments including past, present and future deliveries to thepatient. Additionally, access to administration records of thehospital's administration system 40 is available through the network 5.

[0044] Each bedside CPU 80 can be connected through an appropriateinterface to a variety of peripheral equipment. For example, a barcodereader 90 capable of reading barcodes on a patient's wristband ormedication container; an infusion pump 92 for delivering medication tothe patient in a predetermined, controlled manner; or various sensors 94that can automatically monitor a patient's vital signs and send signalsrepresentative of these vital signs to the computer through anappropriate interface for storage and later retrieval by a selectedsoftware application to provide a graphic display of the patient's vitalsigns during the course of treatment.

[0045] A plurality of bedside CPUs are shown in the drawing; however,more or fewer may exist depending on the particular system and hospitalrequirements.

[0046] Referring now to FIG. 3, a block diagram illustrating the variousapplication software modules comprising the care management system 30 isshown. The care management system's 30 application software is modularin construction to allow installation and operation of the system withonly one or more of the application software groups present. Thisprovides flexibility in meeting the widely varying needs of individualinstitutions where cost and complexity may be an issue or where the fullsystem is not needed. Each of the modular applications, however, isfully integratible into the system.

[0047] The programs of the care management system 30 control alarms oralerts generated by one of the modular applications. Alarms are routedautomatically to the appropriate video display. For example, anocclusion alarm generated by a pump 92 may remain local for apredetermined period. After that period the patient's bedside computer80 may then broadcast the alarm by causing the alarm to be communicatedover the LAN 50 to alert other hospital staff of a potential problem orto cause a particular person responsible for the care of a patient, suchas, for example, a physician or nurse, to be paged.

[0048] Each of the modular applications will now be described in detail.The operation of each of these modular applications in a clinicalsetting will be discussed more fully below. The medical administrationmanagement module 110 integrates medical order information, infusionpump monitoring, and barcode technology to support the real-timeverification and charting of medications being administered to apatient. The medical administration management module 110 creates andmaintains an on-line, real-time, patient-specific medicationadministration record (“MAR”) or integrated medication administrationrecord (“IMAR”) for each patient. This medication administration module110 contains all of the information generated in the institutionregarding the care provided to the patient. The medicationadministration management module 110 gathers information from thevarious nursing and bedside CPU's 70, 80 (FIG. 1) comprising theperipheral hardware of the care management system 30 that is distributedthroughout the institution. For example, when a physician attending apatient diagnoses an illness and determines an appropriate course oftreatment for the patient, the physician may prepare a handwrittenmedical order specifying the desired therapeutic treatment as well asany appropriate parameters such as dosage and/or period ofadministration. The written prescription is sent through theinstitutional mail system to the pharmacy where it is then entered intothe pharmacy information system 20 through a dedicated terminal, orother means, and is then entered into the care management system 30.

[0049] In another embodiment, the physician accesses the pharmacymanagement system 20 through a dedicated terminal or through the caremanagement system 30 via the network 5 using either a nursing CPU 70 ora bedside CPU 80. Alternatively, the treatment order may be entered by anurse or other qualified caregiver into either the pharmacy managementsystem 20 or the care management system 30.

[0050] Referring now to FIGS. 4-6, a variety of implementations of thebarcode identification system of the present invention are shown. FIG.4, for example, shows a patient identification bracelet 170 of the kindtypically used in hospitals and other institutional settings to ensurethat each patient is able to be identified even if the patient isunconscious or other-wise unable to respond to questioning. A barcode175 is printed on a label that is attached to the patient identificationbracelet 170 and has encoded within its sequence of bars the informationnecessary to identify the patient. This barcode may be read using acomputerized barcode reader 68, 90, such as those shown connected to thepharmacy CPU 60 and the bedside CPUs 80 (FIG. 1). The barcode readercomprise a light emitting and receiving wand 95 that is scanned acrossthe barcode. The light emitted by the wand 95 is reflected by thesequence of dark and light lines comprising the barcode into thereceiving lens of the wand 95. A sensor in the wand 95 converts thereceived light into a signal that is then transmitted to the CPU. Asoftware application program running on the CPU then decodes the signalinto the data represented by the barcode in a manner well known to oneskilled in the art. Using appropriate software programs, this data maythen be automatically entered into a database stored in the CPU's memoryor disk storage. While a barcode has been described for purposes ofillustration, those skilled in the art will immediately understand thatother systems, such as magnetic stripes, or programmed punched holes mayalso be used to represent data stored on each label, care giver badge orpatient wrist band.

[0051] Barcode systems are extremely flexible and the amount ofinformation that can be represented by the barcode, while limited, canbe used in a variety of ways. For example, as depicted in FIG. 5, a drugcontainer 185 is identified by a label 180 having a barcode 182 printedthereon. This barcode 182 can represent the patient identification andthe medical order number, and any other information the institutionfinds helpful in dispensing the drug and tracking the treatment. Thebarcode 182 may also be read using a barcode reader, and, using suitableapplication software such as that included within the medicaladministration management module 110, discussed below, can be used tolink the drug container and its contents with the patient identificationbracelet 170 affixed to a patient to ensure the right drug is deliveredto the right patient at the right time in the right manner. The use ofbarcodes is not limited to the implementations discussed above. A sheet190 of barcode labels 177 having barcodes 175 is shown in FIG. 6. Suchlabels can be printed by a printer connected to the pharmacy CPU 60 ofthe care management system 30 or, alternatively, by any other printerconnected to any other hospital information system that can beprogrammed to produce barcodes bearing the information in a form thatcan be read by the barcode readers connected to the various CPUs of thecare management system 30. These barcode labels 177 may then be affixedto clinical devices, patient belongings, or other items where positiveidentification is needed.

[0052] One of the key advantages of the medical administrationmanagement module 110 (FIG. 3) is that the module works in concert withthe barcode labels described above. When the medication administrationmanagement module 110 is implemented using the hardware system describedabove comprising a pharmacy CPU 60, barcode reader 68, and printer 66,together with a bedside CPU 80 with a connected barcode reader 90, thecare management system 30 ensures that medication is administered to theright patient, in the right dose, along the right route and at the righttime.

[0053] When the medication to be administered is of the type that istypically delivered to the patient using an infusion pump, the medicaladministration management module 110 automatically records the starttime of the infusion, queries the pump periodically throughout theinfusion and maintaining a continuous log of the infusion, and recordsthe end time of the infusion and the volume infused in a patient's MAR.If the infusion pump connected to the bedside CPU has a programmabledisplay, the name of the drug, as well as other important informationconcerning the progress of the infusion can be displayed on the infusionpump throughout the infusion to provide a visual display of the statusfor the infusion. One such pump is shown in FIG. 7. The particularinfusion pump depicted in FIG. 8 has three pumping channels. Two of thechannels are displaying the name of the drug being infused.

[0054] Because the medication administration management module 110maintains an on-line, real-time, patient specific graphical medicationadministration record that includes both past, present and futurescheduled medications, a nurse may select a scheduled dosage on the MARand indicate that it will not be administered for specified reasonsselected from a list of options that are dependant upon the healthstatus of the patient at a particular time. This system also allows anurse to select a scheduled dose on the MAR, and record notes andobservations about the dose selected from a list of options. The medicaladministration management module 110 also provides on-line, real-timehelp screens that can be accessed by a nurse or other caregiver todisplay specific information about selected medication and dose to bedispensed.

[0055] The medication administration management module 110 provides alist of on-going infusions that can be displayed on the video display ofthe pharmacy CPU 60 such as is shown in FIG. 8. Drug administrationsthat will terminate within a preselected time period may bedistinguished from other administrations by color highlighting or othermeans. The time remaining, drug, and patient name are presented as wellas buttons for program control.

[0056] The medication administration module 110 records and maintains ina stored file a log of alerts that are generated when any discrepancy isidentified, for example, during the verification process which will bediscussed more fully below. The medication administration module 110also allows the nurse to acknowledge and correct the discrepancy inreal-time, or override the alert by entering the appropriate command.Even where the nurse is allowed to override the alert, the medicationadministration application module 110 prompts the nurse for a reason foreach alert override and then automatically enters the reason into theMAR for the patient.

[0057] The medication administration management module 110 assists thenurse or other health care professional in efficiently delivering careto the patients by providing the ability to perform on-line queries ofthe patient's MARs and produce reports designed to assist the nurse inplanning medication administration and in scheduling the workload ofdispensing the medication to the many patients for which a nursing unitis typically responsible. For example, the video display may be colorcoded to indicate the status and schedule of each drug administration,such as the patient's IMAR shown in FIG. 9. A drug delivery windowextending from thirty minutes prior and thirty minutes after thescheduled administration time may be indicated by a yellow band on thedisplay. Other reports such as the FIG. 10 task list may, for example,include scheduling of drug administrations to ensure proper medicationof the patient while distributing the workload over a period of time toensure that all medication is given promptly. The system may alsodisplay either visuals alerts on the nurse station video display 74 orproduce a printed report on the printer 76 to provide a permanent recordof any medication administration that is running late or has beenrescheduled. The medication administration module 110 may be programmedto operate in an automatic fashion, automatically providing standardreports at the nursing station at predetermined intervals, such as, forexample, every 30 minutes, as determined by the needs of the particularnursing unit and institution.

[0058] The clinical monitoring and event history module 130 shown inFIG. 3 is designed to monitor a variety of clinical devices attached tothe network in a real-time manner and provides information about thosedevices to monitoring stations located elsewhere on the network. Forexample, the clinical monitoring and event history module 130 can beconfigured to monitor a plurality of clinical devices that are in use todeliver medication to patients in the private rooms, semi-private roomsor ward areas in a nursing unit. The clinical monitoring and eventhistory module 130 retrieves real-time data from each device, anddisplays a visual representation of each device including allsignificant data related to its status and settings on the video display74 connected to the Nursing CPU 70 (FIGS. 1 and 2). For example, in thecase where the clinical monitoring and event history module 130 ismonitoring an infusion pump 92, a nurse at the nursing station canaccess the status for that pump wherein the display 74 attached to thenurse CPU 70 then displays information regarding the status of theinfusion being performed at that time. For example, information caninclude the name of the drug being infused, the patient's name, thescheduled start, the actual start of infusion, the scheduled end ofinfusion, the projected end of infusion, the amount of drug infused, theamount of drug remaining to be infused and any alert or discrepancyconditions that may need attention by the nurse. Because the caremanagement system 30 is a fully integrated system, the medicaladministration management module 110 works in concert with the clinicalmonitoring and event history module 130 so that a nurse, doctor ortechnician may, after evaluating the status of the infusion displayed oneither the video display 74 at the nursing CPU 70 or on the videodisplay 84 at the bedside CPU 80 may, by using the touch screen 73, 83of the computer, adjust the infusion regimen accordingly using, forexample, a screen displayed on the video display 74, 84 as shown in FIG.11.

[0059] The clinical monitoring event history module 130 may also beprogrammed to immediately display alarm conditions on remote monitoringscreens, such as the video display 74 attached to the nursing CPU 70, asthe alarm occurs. For example, the status of each patient's infusion canbe represented on a video display at the nursing station as shown by theOVERVIEW computer screen in FIG. 12. When an alert occurs, the boxrepresenting the patient room flashes red to attract attention to thealert. Displaying the alarm condition in this manner allows a nurse toquickly and easily identify the patient from the nursing station andtake appropriate action to address the condition causing the alarm. Thesystem may also be programmed to display certain alarms that have beenidentified as particularly important events at other video displayslocated throughout the institution, such as the video display 64attached to the pharmacy CPU 60 located in the institution's pharmacy.The manner of overview display in FIG. 12 also facilitates recordupdate. For example, when patients move rooms, clicking on the patient'sname, dragging that patient to the new room, and unclicking will causethe records to reflect the patient's move and the display will now showthe patient in that room.

[0060] The clinical device tracking and reporting module 120 shown inFIG. 3 is used to maintain a record of the location of each clinicaldevice and the history of its use in the institution. This systemmaintains a record of the current or last known location within theinstitution of each clinical device used in the institution, such as aninfusion pump or vital sign sensor. Thus, the appropriate equipment canbe easily located by a nurse or a technician for a given therapy regimenor vital sign measurement. This is particularly useful in a largehospital or clinic having many patient rooms, patient beds, or treatmentareas where equipment may be temporarily misplaced. This system is alsouseful in those particular instances where an emergency occurs wheretreatment requires a particular piece of equipment. The status of thatequipment can be easily ascertained from a remote video terminal, suchas the video display 74 connected to the nursing CPU 70.

[0061] The clinical device tracking and reporting module 120 alsomaintains a record containing the usage history of each clinical device,including information about the patient it was used to treat, itslocation, the date, time, duration of use, any alarms that occurred andwhat medications were dispensed. This history may also contain themaintenance and calibration records for a clinical device. Suchinformation can be queried on-line by technicians, nurses or otherhospital administration personnel to generate reports to assist inlocating the clinical device, report on the historical usage of thedevice, and to provide a log of preventative maintenance and equipmentcalibration. The efficient calibration of complex and sensitive clinicaldevices is particularly important in a heath care institution tomaintain accuracy and quality of therapeutic treatment delivery.Maintaining a history of the usage of the device is also helpful tojustify purchasing additional clinical devices when needed, or where therecord indicates that a particular clinical device has become obsoleteand needs to be replaced by a newer model of the device.

[0062] The care management system 30 also includes a consumable trackingmodule 140 that maintains a record of all consumable item usage fortreatment of each patient. This record ensures that appropriate suppliesare ordered and delivered to the nursing unit in a timely andcost-efficient manner to prevent outages of necessary supplies. Suchinformation may also be used by the hospital inventory systems throughan appropriate interface or other management system to ensure that thesupply purchasing is done as cost-effectively as possible. Theconsumable tracking module 140 provides on-line queries and reportgeneration summarizing consumable uses for a particular patient, aparticular nursing unit, or a variety of other purposes.

[0063] The unit management tool module 150 assists nurses in sharinginformation related to patients and automates routine transactionswithin the nursing unit. The unit management tool module 150 allows anurse to record the allergies, handicaps, and special care needs of thepatient which, cooperating with the medication administration recordmodule 110 and the clinical monitoring and event history module 130,displays that information prominently on all appropriate displayscreens, either at the pharmacy video display 64, the nursing videodisplay 74 or at the bedside video display 84 (FIG. 1). The unitmanagement tools module 150 also allows a nurse to record patienttransfers and the times when the patient is out of the room or off thefloor, such as, for example, when the patient is transferred to surgeryor to a different part of the institution for a particular kind oftreatment such as rehabilitative therapy. This system may also beprogrammed to signal an alarm when a patient has been disconnected fromthe system longer than scheduled, for example, when the patientdisconnects from the infusion to attend to personal hygiene. Thisfunction ensures that an alarm or alert is sounded and that appropriatepersonnel are notified of any potential problems and can take thenecessary actions to alleviate the alert condition.

[0064] The knowledge resource tools module 160 provides a framework forinformation sharing among the various units in the hospital and alsosupports an assortment of everyday tools to used by the nurses,physicians and technicians involved in the delivery of health carewithin the institution. This module allows or assists in integratingexternal information sources into the care system 30 to improve theeffectiveness of the care management team in treating the patients inthe institution.

[0065] For example, the knowledge resource tools module 160 provides avariety of on-line tools including, for example, a calculator, a doserate calculator for calculating the appropriate dosage and infusion ratefor a particular drug to be infused into a patient, a standardmeasurement conversion calculator for converting between units ofmeasurement, a skin surface area calculator, and a timer and stopwatch.These resources may be displayed on the video displays 64, 74, 84 atappropriate points within the system, and are available from any CPUeither in the pharmacy, at the nursing station or at the bedside. Theseapplication tools can be programmed to appear on the video display 64,74, 84 either automatically, such as, for example, when an infusion pumpis configured at the start of an infusion to assist in the calculationof a dose rate. These resources may also be available upon entry of theappropriate command by a nurse, physician or technician.

[0066] Referring once again to FIG. 2, a device management subsystem 192is shown and comprises a microcomputer. The subsystem monitors thestatus of the clinical devices, such as the pumps. Alternately, thesubsystem 192 may be included in another microcomputer, such as abedside CPU 80.

[0067] The background monitoring system 195 may also be disposed in astand-alone microcomputer or may be incorporated in an existingmicrocomputer. The subsystem performs background tasks such asmonitoring the status of the interface gateway 27.

[0068] As depicted in FIG. 2, the care management system 30 is connectedto other systems in the institution via an interface 10. This interfacemay support standard health level 7 (HL7) interfaces to the hospital'sother information systems and can also support custom interfaces tosystems or devices that do not support the HL7 standard. The systeminterfaces may be either real-time or batch mode, although a real-timeinterface to a hospital's pharmacy system is required to support theon-line medical administration records keeping function of the medicaladministration management module 110.

[0069] The care management system software can be written to operate ona variety of operating systems to suit the needs of a variety ofinstitutions. In a present embodiment, the software is written tointerface with the nurses and physicians using the Windows environment(Windows is a trademark of Microsoft, Inc.) on IBM compatiblemicro-computers. The Windows environment is well-known by those skilledin the art and will not be described in detail herein. The caremanagement system software, when implemented using the Windows system,is particularly useful in that the Windows operating system provides theability to load several programs at once. Multitasking programs,allowing several application programs to run simultaneously yetproviding immediate access to the various software modules of the caremanagement system 30 may also be used.

[0070] One particular mode of operation of the care management systemwill now be described. As described above, a patient entering a hospitalor other care-giving institution is provided with a wristband necklace,ankle band or other identifier that is affixed to the patient in amanner so that the patient can be identified even if the patient isunconscious or otherwise unresponsive. Such a wristband 170 is depictedin FIG. 4. In one embodiment, the wristband 170 barcode represents thename of the patient and other information that the institute hasdetermined is important and also includes a barcode 175. The informationprinted upon the band, such as name, age, allergies or other vitalinformation is encoded into the barcode 175.

[0071] After the patient is admitted and situated in a bed within theinstitution, the patient is typically evaluated by a physician and acourse of treatment is prescribed. The physician prescribes the courseof treatment by preparing an order, which may request a series oflaboratory tests or administration of a particular medication to thepatient. The physician typically prepares the order by filling in a formor writing the order on a slip of paper to be entered into thehospital's system for providing care.

[0072] If the order is for administration of a particular medicationregimen, the order will be transmitted to the institution's pharmacy.The order will arrive in written form at the pharmacy, will be evaluatedby the pharmacy and processed. The pharmacy then prepares the medicationaccording to the requirements of the physician. The pharmacy packagesthe medication in a container, such as the container 185 shown in FIG.5. Normally, a copy of the order, or at a minimum, the patient's name,the drug name, and the appropriate treatment parameters are representedon a label that is then affixed to the drug container 185. According toone embodiment of the present invention, this information is representedby a barcode 182, that is then printed on a label 180. This barcodelabel 182 may be automatically generated using a printer capable ofprinting barcodes, such as, for example, a printer 69 attached to thehospital's pharmacy information system 20. The existence of thismedication order is made available by the hospital's pharmacyinformation system 20 and is stored by the file server 45.

[0073] Generally, the medication is then delivered to the appropriatecaregiving unit for administering to the patient. A nurse or techniciancarries the drug container 185 to the appropriate patient. In accordancewith one embodiment of the present invention, the nurse or technicianfirst read the barcode 175 on the patient ID bracelet 170 using thebarcode reader 90 connected to the bedside CPU 80. The nurse ortechnician would then read the barcode 182 on the label 180 affixed tothe drug container by swiping the barcode wand 95 across the barcode 182printed on the label 180 of the drug container 185. Additionally, arecord of the identity of the caregiver dispensing the medication may beobtained by reading the barcode 205 printed on an identity badge 200(FIG. 5A) typically worn by all institution personnel.

[0074] For certain drugs, the care-giver is prompted to enter datadescriptive of a selected patient parameter or parameters, such alaboratory value or a current vital sign, before completing theverification process. For example, the care-giver may be prompted tomeasure and enter a value for a patient's blood pressure beforeadministering certain selected drugs. The system may include ranges ofacceptable values for the parameters. If the system detects anout-of-range value for the parameter, the system causes an alarm to beprovided. In an alternative embodiment, the parameters could bemonitored and entered into the system automatically, eliminating theneed for manual entry by the care-giver.

[0075] The data obtained then is analyzed by the medicationadministration management module 110 which records the therapeuticregimen information in the patient's MAR, and verifies that the rightmedication is being given to the right patient in the right dose by theright route and at the right time. If the medication administrationmanagement module 110 detects a discrepancy between the barcodedinformation printed on the patient bracelet 170 and the barcodedinformation on the label 180 affixed to the medication container 185, analert is sounded and the appropriate information is displayed on thevideo display 84 attached to the bedside CPU 80. The nurse or technicianthen either corrects the discrepancy by either re-reading the barcode175 on the patient's bracelet 170 and the barcode 182 on the medicationcontainer 185 or, alternatively, by entering the appropriate informationinto the bedside CPU 80 using the keyboard 82 or touch screen 83, mouse,or other device. In the event that the nurse or technician determinesthat the discrepancy cannot be automatically corrected by re-reading thebarcodes and that the discrepancy is minor and will not affect theaccuracy or safety of the delivery of the medication, the nurse ortechnician may override the alert.

[0076] In an embodiment of the present invention, where the medicationis to be delivered using an infusion pump, such as the infusion pumps 92attached to the bedside CPU 80, the care management system automaticallydownloads information consisting of the appropriate configurationparameters for the infusion from the pharmacy CPU 60 through the localarea network 50 into the bedside CPU 80 and then into the infusion pump92 when the verification function of the medical administrationmanagement module 110 is complete. This is particularly advantageous inthat one potential source of inaccuracy is eliminated by automaticallyconfiguring the pump, thus eliminating the need for the nurse ortechnician to manually enter the parameters necessary to configure theinfusion pump 92. In one embodiment, the infusion pumps 92 comprise IVACCorporation Model 570 volumetric pumps. In an embodiment where the pumpscannot be automatically configured by downloading parameters from thenetwork, the care management system 30 only verifies that the righttreatment is being administered to the right patient. The pump must thenbe manually configured by the physician, nurse or technician.

[0077] Once the infusion pump is configured, the technician then startsthe infusion by pressing the appropriate control on the infusion pump92. Starting pump that is capable of being monitored automatically bythe care management system 30 causes a signal to be transmitted from thepump to the bedside CPU 80 which is then logged by the clinicalmonitoring and event history module 130 and entered by the medicaladministration management module 110 into the patient's MAR. In the casewhere the institution is using a pump that is not capable of beingconfigured by downloading parameters from the network, the nurse orother caregiver logs the start of the infusion using the touch screendevice, mouse or other device connected to the bedside CPU 80. In thiscase, the video displays of the care management system 30 that displayinformation about the status of the infusion will not display real-timedata. Rather, the care management system 30 will project what the statusof the infusion should be given the infusion parameters, the timeelapsed since the infusion began, and any other events that weremanually logged by the caregiver that may have affected the progress ofthe infusion.

[0078] The care management system 30, utilizing the application modulesdescribed above, monitors the infusion process in a real-time manner,providing alerts on the appropriate video display screens locatedthroughout the institution and allows intervention by nurses or othercaregivers at remote locations if necessary. If the pharmacy managementsystem 20 is directly linked to the care management system 30, the caremanagement system 30 may also provide a scheduling report to thepharmacy in determining the status of ongoing infusions, as well as inscheduling the preparing of medications for future infusions.

[0079] In another embodiment, the present invention includes a “CodeMode” that allows a care-giver to bypass the system to immediately causea list of drugs that have been preselected by the institution to be usedin an emergency situation. The initiation of the “Code Mode” causes atime-stamp to be placed in the patient's MAR along with the identity ofthe drug selected from the displayed list of drugs to be used to treatthe emergency. This feature ensures that the emergency, and thetreatment used to address the emergency, are accurately recorded in thepatient's MAR.

[0080] While one particular embodiment of the present invention has beendescribed above, alternative configurations of the care managementsystem network are possible. For example, one alternative embodiment ofthe care management system 30 is depicted in FIG. 13. In thisconfiguration, clinical devices 210 are connected by means ofappropriate interfaces and cabling 215 to a bedside data concentrator220 which would typically be located outside of a private room,semi-private room or ward area. In this configuration, there is nobedside CPU 80 as described previously. Instead, the bedside dataconcentrator 220 is connected through an appropriate interface andcabling to the local area network 50, where the data gathered from theclinical devices 210 is then available for processing by the caremanagement system 30 and display at the various monitoring stations,such as either in the pharmacy or at the nurse station 70. In thisembodiment, there is no bedside CPU 80 having a keyboard 82 for dataentry or a video display 84 for display of either clinical deviceinformation or patient information.

[0081] A further embodiment of the care management system 30 local areanetwork is depicted in FIG. 14. In this embodiment, the file server andmonitoring stations are connected using appropriate interfaces andethernet cabling to an RF data concentrator 225. At the bedsidelocations in the private rooms, semi-private rooms or ward areas of theinstitution, the clinical devices 210 and barcode reader 90 at thebedside are connected to an RF transmitter/receiver 230. This RFtransmitter/receiver 230 transmits the information gathered from theclinical devices 210 and the barcode reader 90 to the RF dataconcentrator 225 attached to the local area network 50. Thus, expensivecabling is not required to connect every patient treatment area.Additionally, flexibility in locating the clinical devices 210 andbarcode reader 90 is obtained as well as allowing the ability toreconfigure the patient treatment area without costly rewiring of theethernet cabling.

[0082] Yet another embodiment of the care management system 30 localarea network 50 configuration is shown in FIG. 15. In thisconfiguration, the ethernet cabling connecting the pharmacy CPU, thenurse station nursing CPU 70 and bedside CPUs and clinical devices iseliminated entirely. Each hardware element, comprising the file server,nursing CPU 70, pharmacy CPU 60 and bedside CPUs 80 and clinical devicesand/or barcode readers is connected to an RF transmitter/receiver 230.In this manner, all of the information is transmitted throughout thelocal area network 50 by way of radio transmission rather than by usingcostly network cabling. Such a system would additionally allow for theuse of portable computers 235 having RF transmitter/receivers 230 thatcould then be carried with physicians, nurses or technicians as theycirculate through the institution. With this configuration, caregivingpersonnel could access the care management system either spontaneouslyor upon notification of an alert no matter where they were in theinstitution at any given time. Such a system would be particularlyuseful in a large institution where caregiving personnel are likely tobe responsible for many hospital beds or when personnel are out of thearea or off the floor.

[0083] Another embodiment of the care management system 30 is shown inFIG. 16. In this embodiment, the patient 245 and/or caregiver havebadges or wrist bands 240 that may also include electronic circuitrythat is responsive to signals from a transmitter/receiver 230 located ineach patient room or treatment area to automatically provide the caremanagement system 30 (FIG. 1) with the identity of, and possibly otherselected information about, the occupants of the patient room ortreatment area, eliminating the need to use a bar-code reader to readthe bar-codes on the patient and/or caregiver badges or wrist bands.Such a system may be described as a passive recognition system in thatneither the patient nor the caregiver need take any active steps toinform the care management system 30 of their location within theinstitution.

[0084] One example of such a system incorporates an intelligent RFcomputer chip into the caregiver or patient badge or wristband 240 thatprovides a unique, or programmed response with a passive RF transponder230 located within a patient room or treatment area, such as in theframe 231 of the entry or exit of the room or treatment area, or mountedon a wall or ceiling. Each badge or wrist band 240 interacts withsignals of the transponder 230 in a unique way, the unique interactionrepresenting an assigned code for the badge or wristband 240. Utilizingthis technology would remove manual steps and some of the “human factor”from the process of identifying the patient and caregiver.

[0085] When an individual 245 wearing a badge or wristband 240 havingsuch a circuit enters a room or area where a transmitter/receiver 230 islocated, the electronic circuit in the badge or wristband 240 interactswith signals emitted by the transmitter without any positive action onthe part of the caregiver or the patient. This interaction may be sensedby the receiver, which may be capable of determining the identity of thebadge or wristband 240 from the interaction of the electronic circuitwith the emitted signals. Alternatively, the receiver may simply sensethe interaction and provide a signal representative of the sensedinteraction to a computer or other processor which has been programmedor otherwise configured to determine the identity of the individualassociated with that particular badge or wristband 240.

[0086] Although the preceding paragraphs describe a passive recognitionsystem using electrical circuitry, other approaches may also be used.For example, it can be envisioned that the patient and/or caregiver mayhave magnetically-encoded devices that can be automatically read by anappropriate detector located in the patient room or treatment area.

[0087] Such a system is advantageous in that it can also be used totrack the location of patients and caregivers in an institution. Thisinformation would be useful to monitor patient movements, especially inthe case of patients with reduced mental capacity who may be prone towandering about the institution. It would also be useful to know thelocation of the caregivers within an institution so that in the event ofan emergency, the caregiver could be quickly located.

[0088] While several forms of the invention have been illustrated anddescribed, it will also be apparent that various modifications can bemade without departing from the spirit and scope of the invention.Accordingly, it is not intended that the application be limited, exceptby the appended claims.

1. A system for programming a clinical device to deliver medication to apatient comprising: a terminal operatively connected to the clinicaldevice; a processor having a memory in which is stored identificationdata, clinical device data and patient treatment data, the patienttreatment data including medication identification data and clinicaldevice operation parameters associated with the medicationidentification data for programming the clinical device to deliver themedication to the patient; means for detecting an identity of thepatient, the means for detecting operatively connected to the processorfor input of identification data to the processor; input meansoperatively connected to the processor for input of identification data,patient data, clinical device data and patient treatment data, whereinthe processor stores the identification data, patient data, clinicaldevice data and patient treatment data in the memory; communicationmeans for operatively connecting the terminal and the detecting means tothe processor, wherein identification data from the detecting means iscommunicated to the processor by the communication means; wherein theprocessor compares the communicated identification data to the storedidentification data; and wherein the processor downloads the clinicaldevice operating parameters associated with the patient treatment datato the terminal to program and operate the clinical device in accordancewith the downloaded operating parameters in response to an acceptablecomparison of the identification data by the processor.
 2. The system ofclaim 1, wherein the means for detecting comprises a passiveidentification system for passively identifying individuals.
 3. Thesystem of claim 2, wherein the passive identification system comprisesan RF transponder.
 4. The system of claim 3 further comprising anidentification device located on an individual; wherein the RFtransponder interacts with the identification device to provide a signalto the processor representing the identity of the individual.
 5. Thesystem of claim 4 wherein the identification device comprises anelectrical circuit.
 6. The system of claim 1 wherein the memory alsostores clinical device location data.
 7. The system of claim 6 whereinthe terminal is operable to receive clinical device location data fromthe clinical device and the communication means is also forcommunicating clinical device location data, wherein the terminalcommunicates the clinical device location data through the communicationmeans to the processor and the processor stores the clinical devicelocation data in the memory.
 8. The system of claim 1 wherein the memoryalso stores clinical device usage data.
 9. The system of claim 8 whereinthe terminal is operative to receive clinical device usage data from theclinical device and the communication means is also for communicatingclinical device usage data, wherein the terminal communicates theclinical device usage data through the communication means to theprocessor and the processor stores the communicated clinical devicestorage data in the memory.
 10. The system of claim 1 wherein the memoryalso stores clinical device maintenance data.
 11. The system of claim 10wherein the first terminal is operative to receive clinical devicemaintenance data from the clinical device and the communication means isalso for communicating the clinical device maintenance data, wherein theterminal communicates the clinical device maintenance data to theprocessor and the processor stores the communicated clinical devicemaintenance data in the memory.
 12. The system of claim 1 wherein theidentification data and the clinical device operating parameters storedin the memory comprise medical administration records.